QA Manager

Open Scientific; Deer Park (NY); On-site; USD 70,000 - 80,000; Full time

Job summary

Open Scientific is seeking an experienced QA Manager to oversee quality systems for a label manufacturer serving clinical trials and investigational drug products. The ideal candidate will have at least 5 years of management experience in the pharmaceutical/nutraceutical/food industry and hands-on GMP compliance.

This role includes writing and approving SOPs, leading a 22-person quality team, coordinating customer audits, calibration programs, validation (IQ/OQ/PQ), and maintenance of MSDS and

Qualifications

• Minimum 5 years of management experience in pharma/nutraceutical/food industries.

Responsibilities

• Oversee all quality systems for the label manufacturer of clinical trials and investigational drug products.
• Manage a staff of 22 including 3 managers and 2 supervisors.
• Develop, write, revise and approve all SOPs.
• Lead customer audits and respond to audit findings.
• Implement calibration programs, mock recalls, AQL sampling plans, line clearance methods.

Skills

QA Management

SOP Development

Audits & Compliance

GMP Knowledge

Tools

IQ/OQ/PQ Validation

Job description

Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

Job Description

An ever growing company is looking for an experienced QA Manager. The ideal candidate has at least 5 years of management experience in the pharmaceutical/nutraceutical/food industry.

Pay: $70,000 to $80,000

Responsibilities & Duties:

• Responsible for all quality systems for label manufacturer of clinical trials and investigational
  drug products.
• Responsible for a staff of 22 individuals, including 3 Managers and 2 supervisors.
• Develop, write, revise and approve all SOPs.
• Solely responsible for customer audits, including audit responses.
• Instituted company-wide calibration program, effectiveness training, mock recalls, AQL
  statistical sampling plans, line clearance methods and specifications for components.
• Developed code system for customer complaints, investigations, utilized in trending analysis.
• Developed training matrices for all employees.
• Responsible for cGMP and SOP training programs.
• Write and execute validation protocols - Installation Qualification (IQ), Operational
  Qualification (OQ) and Performance Qualification on various equipment
• Complete customer Quality Agreements, Technical Agreements and questionnaires.
• Revised and enhanced preventative maintenance program, ensuring overall compliance.
• Maintain Material Safety Data Sheet (MSDS) manuals, facility pest control and emergency
  lighting programs.

Additional Information

All your information will be kept confidential according to EEO guidelines.